PHENYTOIN SODIUM

Product NDC
67296-1251
11-digit product format
672961251
Labeler code
67296
Product ID
67296-1251_9c9f4448-d8bf-9258-e053-2a95a90a532f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040621
Marketing category
ANDA
Marketing start
2006-12-12
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1251-62022-01-28C16284748780-1d6a99b39-d31c-a426-e053-dadaa90af4c25268708d-770f-0a29-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1251-6PHENYTOIN SODIUM60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1251PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20200121_5268708d-770f-0a29-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN5268708d-770f-0a29-e054-00144ff88e882
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD5268708d-770f-0a29-e054-00144ff88e882
855671DPH sodium 100 MG Extended Release Oral CapsuleSY5268708d-770f-0a29-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1251-66729612510660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67296-1251-6) 2006-12-120000-00-00NoNoCurrent